June 17, 2015 — The family of a baby girl who was exposed to Zofran in the womb and died from heart defects has filed a lawsuit against GlaxoSmithKline (GSK) for failing to warn about the risk.

The lawsuit (PDF) was filed in the U.S. District Court for the Northern District of Ohio (Case No. 3:15-cv-1166) by the family of Molly Regan.

While pregnant with her first child, plaintiff Valerie Regan suffered from morning sickness and was prescribed Zofran as an “off-label” treatment to prevent nausea and vomiting. She took Zofran and had an otherwise unremarkable pregnancy until nine days before the delivery, when her unborn baby’s heart rate began to slow down.

Molly Regan was born in March 2006 and diagnosed with a right ventricular heart defect. When she was just three days old, she “crashed” and doctors were unable to save her life.

GSK is accused of negligence for marketing Zofran to pregnant women and failing to warn about the risk of birth defects. According to the complaint:

“GlaxoSmithKline actively concealed information and actively misled the Regans, their physician, the medical community in general, the public at large, and federal regulators regarding Zofran’s propensity to cause birth defects and its appropriateness for use by pregnant mothers.”

In the last few years, several studies have found evidence that babies exposed to Zofran during the first trimester are more likely to be born with heart defects. One study involving over 900,000 births in Denmark concluded that Zofran doubled the risk of having a baby with a heart defect. Another study published last year found higher rates of “hole in the heart” defects, including ventricular septal defect.


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